BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONESCALPEL® HANDPIECE

    MDR report key: 16696536 · Received April 6, 2023

    Report

    Report Number
    2435119-2023-00004
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Date of Event
    February 23, 2023
    Report Date
    April 6, 2023
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K070313
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON MARCH 1, 2023, MISONIX LLC., A BIOVENTUS CO., RECEIVED A PRODUCT OCCURRENCE REPORT ON A SONICONE O.R. ULTRASONIC GENERATOR, (PART NUMBER E-SOGEN-OR, SERIAL NUMBER (B)(4)) THAT OCCURRED ON (B)(6) 2023, DURING AN OMF NERVE LATERALIZATION PROCEDURE. SPECIFICALLY, THE REPORT INDICATED THAT TWO HANDPIECES USED BECAME HOT AND BURNED THE SURGEON AND THE PATIENT. THE FOLLOWING ACCESSORIES WERE USED: BONESCAPEL HANDPIECES, PART NUMBER BCM-HP, SERIAL NUMBERS (B)(4). BONESCALPEL MICROHOOK, STANDARD SHAVER, PART NUMBER MXB-S1, LOT NUMBER 223091. THE DEGREE OF THE BURN TO THE SURGEON WAS NOT REPORTED. THE DEGREE OF BURN TO THE PATIENT WAS NOT REPORTED. THE PATIENT BURN WAS DESCRIBED AS "A VERY SMALL PINPOINT SLIGHTLY WHITE POINT ON THE LIPS" AND "THE BURN WAS SO SMALL IT WAS NOT NOTICEABLE AFTER THE CASE." MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY TO THE SURGEON OR PATIENT WAS NOT REPORTED. PERMANENT IMPAIRMENT TO BODY STRUCTURE OR BODY FUNCTION WAS NOT REPORTED. THE DEVICE HISTORY RECORDS FOR THE SONICONE O.R. ULTRASONIC GENERATOR, (PART NUMBER E-SOGEN-OR, SERIAL NUMBER (B)(4)), BONESCALPEL HANDPIECES (PART NUMBER BCM-HP, SERIAL NUMBERS (B)(4)), AND BONESCALPEL MICROHOOK, STANDARD SHAVER, PART NUMBER MXB-S1 LOT NUMBER 223091 WERE REVIEWED. THE REVIEW INDICATED THAT THESE DEVICES WERE MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. THERE WERE NO DEVIATIONS FOUND DURING IN-PROCESS OR FINAL INSPECTION. INSPECTION AND TEST RESULTS MET SPECIFICATIONS PRIOR TO RELEASE TO COMMERCE. THE SUBJECT GENERATOR AND HANDPIECES WERE RETURNED TO MISONIX FOR EVALUATION. THE DISPOSABLE WAS DISCARDED AFTER THE CASE AND WAS NOT AVAILABLE FOR EVALUATION. INSPECTION AND TESTING ON THE GENERATOR CONFIRMED THE GENERATOR MET SPECIFICATIONS. NO MALFUNCTIONS THAT WOULD CAUSE OR CONTRIBUTE TO A USER/PATIENT BURN WERE NOTED. BOTH HANDPIECES WERE TESTED WITH THE RETURNED GENERATOR. THE BONESCALPEL HANDPIECE (SERIAL NUMBER (B)(4)) MET SPECIFICATIONS AND EXHIBITED NORMAL TEMPERATURES. A SINGLE FAULT CONDITION WAS IDENTIFIED ON BONESCALPEL HANDPIECE (SERIAL NUMBER (B)(4)). THE HANDPIECE EXHIBITED NORMAL OPERATING TEMPERATURES WHEN TESTED IN THE FAULT CONDITION. THE HANDPIECE WAS REPAIRED AND TESTED. THE HANDPIECE PASSED ALL SPECIFICATIONS AFTER REPAIR. A REVIEW OF POST-MARKET SURVEILLANCE INFORMATION DID NOT SHOW ANY SIGNIFICANT ADVERSE TRENDS FOR USER OR PATIENT BURNS. THE CURRENT FREQUENCY OF OCCURRENCE FOR USER OR PATIENT BURNS IS WITHIN THE FREQUENCY ORIGINALLY ESTIMATED IN THE ORIGINAL RISK MANAGEMENT REPORT. THEREFORE, THERE IS NO CHANGE TO THE RESIDUAL RISK OR RISK-BENEFIT RATIO. THE INSTRUCTIONS FOR USE MANUAL (BCM-UM REVISION U) FOR THE BONESCALPEL SYSTEM CONTAINS THE FOLLOWING WARNINGS AND CAUTIONS REGARDING THE SURGICAL TECHNIQUE AND DEVICE SETTINGS REQUIRED TO PREVENT THERMAL INJURY: WARNING 1.2 THE BONESCALPEL SYSTEM IS INTENDED TO BE USED IN VARIOUS TYPES OF INVASIVE, SURGICAL PROCEDURES. THERE MAY BE INDIRECT DANGER TO THE PATIENT SHOULD THE DEVICE FAIL DURING THE PROCEDURE. IT IS RECOMMENDED THAT THE FACILITY FOLLOWS ITS BACK-UP EQUIPMENT PROTOCOLS. WARNING 3.1 TIP AND IRRIGANT TEMPERATURES MAY EXCEED THE TISSUE NECROSIS POINT IF INSUFFICIENT IRRIGATION FLOW RATES ARE USED. FOR HARD TISSUE REMOVAL, SET THE IRRIGATION FLOWRATE TO A SETTING NO LESS THAN THE COMPARABLE VIBRATION SETTING. FOR EXAMPLE, IF THE VIBRATION SETTING IS 7, A MINIMUM FLOW SETTING OF 70% SHOULD BE USED. ADDITIONAL EXTERNAL IRRIGATION, E.G. BY ADMINISTERING STERILE SALINE WITH A SYRINGE OVER THE DISTAL TIP PORTION, MAY BE NECESSARY FOR REMOVAL OF VERY DENSE, HARD OSSEOUS STRUCTURES. WARNING 3.2 TISSUE NECROSIS MAY RESULT IF TIP IS NOT MOVED RELATIVE TO TISSUE. A CONTINUOUS, LATERAL SWEEPING MOTION IS RECOMMENDED IN ORDER TO MINIMIZE CONTACT DURATION WITH THE ULTRASONIC TIP AND MINIMIZE HEAT BUILD-UP. WHEN LATERAL MOTION IS NOT POSSIBLE WITHDRAW AND RE-INSERT TIP FREQUENTLY. WARNING 4.1 CONTACT TO VIBRATING ELEMENTS LIKE EXTENSION AND ULTRASONIC TIP MAY CAUSE BURNS AND SHOULD BE AVOIDED BY ALL MEANS. THE HANDPIECE SHOULD ONLY BE HELD AT THE BLACK HOUSING AREA. AN OPTIONAL, PROTECTIVE SILICONE SLEEVE, INCLUDED WITH CERTAIN TIPS, REDUCES THE RISK OF THERMAL DAMAGE BUT DOES NOT ELIMINATE IT. CONTACT WITH THE SILICONE SLEEVE SHOULD BE AVOIDED OR KEPT BRIEF WITH MINIMAL AMOUNT OF CONTACT PRESSURE. PRESSURE AND EXTENDED EXPOSURE CAN STILL RESULT IN EXCESSIVE FRICTIONAL HEAT AND CAUSE BURNS. WARNING 7.3 HEAT IS BEING GENERATED AT THE TIP/TISSUE INTERFACE. A CONTINUOUS, LATERAL SWEEPING MOTION IS RECOMMENDED FOR GENERAL BONE/TISSUE REMOVE IN ORDER TO MINIMIZE CONTACT DURATION WITH THE ULTRASONIC TIP AND MINIMIZE THE TEMPERATURE INCREASE. CAUTION 4.2 INSUFFICIENT IRRIGATION AND HIGH TIP PRESSURE (LOADING) UNDER EXTENDED EXPOSURE, E.G., IN TIGHT CAVITIES, ARE TO BE AVOIDED IN SONICONE O.R. HARD TISSUE REMOVAL. IT IS RECOMMENDED TO WITHDRAW AND RE-INSERT THE ULTRASONIC TIP REPEATEDLY TO RE-ESTABLISH ADEQUATE COOLING AND LUBRICATION. CAUTION 7.7 PRIME THE IRRIGATION TUBING PRIOR TO USE. AT ALL TIMES ENSURE THAT THE IRRIGATION FLOWS TOWARDS THE HANDPIECE WHEN FOOTSWITCH IS DEPRESSED. IF NO IRRIGATION IS FLOWING, CEASE USE UNTIL FLOW IS RESTORED. CAUTION 7.8 THE SYSTEM CHECK SHOULD ALWAYS BE DONE IN ADVANCE OR PREPARING PATIENT FOR SURGERY TO MINIMIZE RISK TO PATIENT IN CASE OF SYSTEM MALFUNCTION. IRRIGATION PROPER IRRIGATION WITH STERILE SALINE ENSURES: 1. COOLING OF HANDPIECE AND VIBRATING ELEMENTS 2. COOLING AND LAVAGE OF THE SURGICAL SITE 3. LUBRICATION OF BONE/TIP INTERFACE FOR SONICONE O.R. HARD TISSUE REMOVAL THE ACTIVE ULTRASONIC PROBE REMAINS COLD WHEN NOT IN CONTACT WITH TISSUE. HOWEVER, WHEN A TIP CONTACTS TISSUE HEAT IS GENERATED. THE HEAT INCREASES WITH APPLIED TIP PRESSURE OR AMPLITUDE. IRRIGANT NEEDS TO BE APPLIED AT THE TIP/TISSUE INTERFACE TO MITIGATE THIS TEMPERATURE RISE. MOST ULTRASONIC TIPS AND PROBES FEATURE AN INTEGRATED IRRIGATION CHANNEL. THE IRRIGANT IS EXPELLED THROUGH A JET NOZZLE AT THE TIP. ACTIVE TIP SURFACES ARE BEING COOLED DIRECTLY. THE CONSOLE MONITORS THE ELECTRICAL OUTPUT AT ALL TIMES AND ALERTS IN CASES WHERE THE HANDPIECE IS NOT PROPERLY CONNECTED TO THE CONSOLE, WHEN AN OUTPUT SHORT OR OPEN CIRCUIT IS DETECTED OR ELECTRICAL SAFETY IS COMPROMISED. AN ELECTRICAL FAULT SCREEN IS DISPLAYED TOGETHER WITH A STEADY AUDIBLE INDICATOR. ULTRASOUND AND IRRIGATION ARE DEACTIVATED. REQUIRES RECYCLING OF MAINS POWER SWITCH TO RE-SET. WARNING 6.1 IMMEDIATELY SUSPEND OPERATION IF ELECTRICAL FAULT APPEARS ON DISPLAY AND/OR AN ELECTRICAL FAULT AUDIBLE INDICATOR SOUNDS. REMOVE ULTRASONIC TIP FROM SURGICAL SITE. TURN MAINS POWER OFF. DO NOT TOUCH ANY METALLIC PARTS OF HANDPIECE, EXTENSION, ULTRASONIC TIP OR GENERATOR WHILE FAULT IS INDICATED. THE SYSTEM MEETS THE REQUIREMENTS FOR LEAKAGE CURRENT IN ACCORDANCE WITH UL 60601-1 MEDICAL ELECTRICAL EQUIPMENT, PART 1: GENERAL REQUIREMENTS FOR SAFETY, AND IEC 60601-1 MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (3RD EDITION) FOR ALL NORMAL AND SINGLE FAULT CONDITIONS FOR TYPE B APPLIED PARTS. SPECIFICALLY, THE GENERATOR CONSOLE MONITORS THE ELECTRICAL OUTPUT TO THE HANDPIECE AT ALL TIMES. IF THERE IS AN IMBALANCE OF CURRENT THE GENERATOR AUTOMATICALLY DISABLES THE ULTRASOUND OUTPUT TO PREVENT UNSAFE PATIENT OR USER LEAKAGE CURRENT. FAULT CODES ARE DISPLAYED ON THE FRONT PANEL AND AN AUDIBLE TONE CAN BE HEARD. THE PATIENT CIRCUIT IS A FLOATING GROUND, LIMITING LEAKAGE CURRENT. THE IFU LISTS CORRECTIVE ACTIONS TO CLEAR FAULT MESSAGES OR RETURN THE DEVICE TO MISONIX IF FAULT MESSAGES RECUR.

    Description of Event or Problem · 0

    ON MARCH 1, 2023, MISONIX LLC., A BIOVENTUS CO., RECEIVED A PRODUCT OCCURRENCE REPORT ON A SONICONE O.R. ULTRASONIC GENERATOR, (PART NUMBER E-SOGEN-OR, SERIAL NUMBER (B)(4)) THAT OCCURRED ON (B)(6) 2023, DURING AN OMF NERVE LATERALIZATION PROCEDURE. SPECIFICALLY, THE REPORT INDICATED THAT TWO HANDPIECES USED BECAME HOT AND BURNED THE SURGEON AND THE PATIENT. THE FOLLOWING ACCESSORIES WERE USED: BONESCAPEL HANDPIECES, PART NUMBER BCM-HP, SERIAL NUMBERS (B)(4). BONESCALPEL MICROHOOK, STANDARD SHAVER, PART NUMBER MXB-S1, LOT NUMBER 223091. THE DEGREE OF THE BURN TO THE SURGEON WAS NOT REPORTED. THE DEGREE OF BURN TO THE PATIENT WAS NOT REPORTED. THE PATIENT BURN WAS DESCRIBED AS "A VERY SMALL PINPOINT SLIGHTLY WHITE POINT ON THE LIPS" AND "THE BURN WAS SO SMALL IT WAS NOT NOTICEABLE AFTER THE CASE." MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY TO THE SURGEON OR PATIENT WAS NOT REPORTED. PERMANENT IMPAIRMENT TO BODY STRUCTURE OR BODY FUNCTION WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519823 BONESCALPEL® HANDPIECE BONESCALPEL® HANDPIECE LFL MISONIX, INC. BCM-HP 2503-14-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other